REGULATORY AUTHORITY:
Dirección Nacional de Medicamentos (DNM)
CLASSIFICATION SYSTEM:
Medical Devices/IVDs: I/IIa/IIb/III.
TIMEFRAME:
According to our experience, new product registration in El Salvador will take around 5-6 months (depending on risk classification).
SPECIAL REQUIREMENT:
Local testing and clinical study are not required.
LOCAL FEES (New Application):
New registration (all classes) – USD 75
LOCAL FEES (Manufacturer):
Not applicable
LICENSE VALIDITY:
The registration certificate is valid for 5 years.
LICENSE TRANSFER:
License transfer is possible. The new certificate holder must submit the paperwork.
AUTHORIZED REPRESENTATIVE:
A foreign manufacturer must appoint a local company to become their authorized representative.
ADDITIONAL INFORMATION:
Not applicable.
Other Central America and the Caribbean Countries: Belize, Costa Rica, Cuba, Dominican Republic, Guatemala, Honduras, Nicaragua, Panama
Last Update January 2023
